Flagstaff, AZ, United States
W L Gore & Associates, Inc. recalls
19 recalls recorded since 2018, most recently on 3 September 2026. 15 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)15
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 September 2026
- Reason
- The potential for the devices to be mislabeled with the incorrect length.
- Distribution
- US Nationwide distribution in the states of GA, RI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0158-2027
- Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosth
Ongoing Class II Medical devices
- Recall started
- 22 May 2026
- Reason
- 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- Distribution
- U.S. Nationwide distribution in the states of GA and RI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2914-2026, Z-2915-2026
- GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Ongoing Class II Medical devices
- Recall started
- 19 May 2026
- Reason
- Due to catheter separation
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI. The countries of United Arab Emirates, Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2672-2026
- GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB
Ongoing Class II Medical devices
- Recall started
- 26 August 2025
- Reason
- Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
- Distribution
- US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI. OUS: PANAMA, CANADA, CHINA, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0036-2026
- GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH4700
Ongoing Class II Medical devices
- Recall started
- 3 July 2024
- Reason
- Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
- Distribution
- US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2513-2024
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Ongoing Class II Medical devices
- Recall started
- 1 July 2024
- Reason
- Due to packaging defects, sterility assurance and heparin activity may be compromised.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2945-2024, Z-2946-2024
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BX
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085
Ongoing Class II Medical devices
- Recall started
- 19 January 2024
- Reason
- Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
- Distribution
- US Nationwide distribution in the state of Georgia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1179-2024
- GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Ongoing Class II Medical devices
- Recall started
- 14 December 2022
- Reason
- Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
- Distribution
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1048-2023
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Ongoing Class II Medical devices
- Recall started
- 21 September 2022
- Reason
- Due to manufacturing records (Release Test Results) indicating "Failed".
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0136-2023
- GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Ongoing Class II Medical devices
- Recall started
- 7 September 2021
- Reason
- Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
- Distribution
- International distribution to the countries of Italy & Lebanon.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0077-2022
- Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
Ongoing Class II Medical devices
- Recall started
- 2 September 2021
- Reason
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Distribution
- US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0172-2022, Z-0166-2022, Z-0169-2022, Z-0165-2022, Z-0170-2022, Z-0171-2022, Z-0167-2022, Z-0164-2022, Z-0168-2022
- REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
- REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
- REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
- REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
- REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
- REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
- REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
- REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 July 2021
- Reason
- Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2340-2021
- Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Ongoing Class II Medical devices
- Recall started
- 12 May 2021
- Reason
- Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
- Distribution
- US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2292-2021, Z-2293-2021
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
Terminated Class II Medical devices
- Recall started
- 5 April 2021
- Terminated
- 16 January 2024
- Reason
- The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1593-2021
- GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the
Ongoing Class II Medical devices
- Recall started
- 9 September 2020
- Reason
- When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
- Distribution
- U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0291-2021
- GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Ongoing Class II Medical devices
- Recall started
- 9 September 2020
- Reason
- Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
- Distribution
- U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0290-2021
- GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Terminated Class II Medical devices
- Recall started
- 6 January 2020
- Terminated
- 9 August 2022
- Reason
- Firm has received reports of leading end catheter component separations.
- Distribution
- US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; N
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0995-2020, Z-0996-2020
- GORE¿ EXCLUDER¿ AAA Endoprosthesis
- GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Terminated Class II Medical devices
- Recall started
- 17 December 2019
- Terminated
- 28 April 2021
- Reason
- The incorrect label was placed on both the primary and secondary package.
- Distribution
- International the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2052-2020
- Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 13 May 2020
- Reason
- The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
- Distribution
- All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1962-2020
- Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.